Adjunctive Corticosteroid Therapy for Pediatric Catecholamine-Dependent Septic Shock: A Pilot Study
- Conditions
- Catecholamine-Dependent septic shockChildrenSeptic shockHydrocortisoneCorticosteroidsShock reversal
- Registration Number
- TCTR20190219003
- Lead Sponsor
- Siriraj research development fund (managed by routine to research)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 80
All children 6 months †18 years of age with septic shock who require vasoactive-inotropic support in the pediatric IC
•Pre-existing hypothalamic-pituitary-adrenal axis dysfunction
•History of long term corticosteroid use within 6 months or short term corticosteroid use within past 4 weeks
•History of etomidate or ketonazole use within past 7 days
•HIV infection
•Skin lesion described as purpura fulminans
•History of receiving vasoactive-inotropic drugs > 24 hours before enrollment
•Diabetes mellitus
•Blood sugar ≥180 mg/dL before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to shock reversal until dischagre form ICU Time to maintain SBP > 5th percentile + without vasoactive-inotropic support for at least 24 hrs
- Secondary Outcome Measures
Name Time Method ength of PICU stay ICU admission date to ICU discharge date days,Length of hospital stay until discharge from hospital days,28 day-mortality Death from any causes at 28 days after enrollment Mortality rate ,Continuous renal replacement therapy requirement Until discharge form ICU The proportion of CRRT patients,Blood product requirement Until dischagre form ICU The proportion of required blood transfusion patients,Organ dysfunction free days Free from organ failure at 28 days after enrollment days,Adverse effects Adverse effects at 7 days after enrollment The proportion of adverse effects